The following data is part of a premarket notification filed by Femsuite, Llc with the FDA for Femeye Two.
| Device ID | K093218 |
| 510k Number | K093218 |
| Device Name: | FEMEYE TWO |
| Classification | Hysteroscope (and Accessories) |
| Applicant | FEMSUITE, LLC 19991 7TH STREET EAST Sonoma, CA 95476 |
| Contact | Pavan Sethi |
| Correspondent | Pavan Sethi FEMSUITE, LLC 19991 7TH STREET EAST Sonoma, CA 95476 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-13 |
| Decision Date | 2010-05-18 |
| Summary: | summary |